Chemotherapy Plus Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed

NCT ID: NCT00003803

Last Updated: 2012-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-02-28

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy used high-energy x-rays to damage tumor cells. It is not yet know whether chemotherapy followed by radiation therapy is more effective than chemotherapy given with radiation therapy for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of two different regimens of chemotherapy and radiation therapy in treating patients who have unresectable stage I, stage II, or stage III non-small cell lung cancer.

Detailed Description

OBJECTIVES:

• Compare survival, disease-free survival, local control, and pattern of recurrence in patients with unresectable stage I, II, or low-volume stage III non-small lung cancer treated with high-dose radiotherapy either preceded by induction chemotherapy with gemcitabine and cisplatin or combined with daily cisplatin.
• Compare the acute and late toxic effects of these regimens in these patients.
• Determine the quality of life of these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to performance status (0 vs 1), TNM stage, and participating center. Patients are randomized to one of two treatment arms.

• Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 3-6 hours on day 2. Treatment is repeated once 21 days later. Patients undergo high-dose accelerated conformal radiotherapy beginning on week 9 (day 57), 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy.
• Arm II: Patients receive low-dose cisplatin IV followed 1-2 hours later by high-dose accelerated conformal radiotherapy. Treatment continues daily, 5 days a week, for 24 fractions, using a concurrent boost technique up to 66 Gy.

Quality of life is assessed before treatment and at weeks 9-11, 19, 27, and 35.

Patients are followed at 3 weeks, 6-7 weeks, and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 418 patients (209 per arm) will be accrued for this study within 5 years.

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancer; stage II non-small cell lung cancer; stage III non-small cell lung cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

cisplatin

Intervention Type: DRUG

gemcitabine hydrochloride

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer

• Stage I, II, III (T1-4, N0-3, M0)

• No metastases to supraclavicular, contralateral hilar, or contralateral scalene lymph nodes
• Medically inoperable or unresectable
• No pleural or pericardial effusion (except with repeated negative cytology)

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• ECOG 0 or 1

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 6.8 g/dL
• No hemoptysis causing a decrease of hemoglobin of 1 g/dL or more within 24 hours

Hepatic:

• Not specified

Renal:

• Creatinine no greater than 1.25 times normal OR
• Creatinine clearance greater than 70 mL/min

Cardiovascular:

• No evidence of heart failure
• No myocardial infarction within the past 6 months
• No superior vena cava syndrome

Pulmonary:

• FEV1 at least 1 L
• No pre-existing fibrotic lung disease
• No postobstructive pneumonia preventing exact delineation of tumor volume
• Diffusion capacity at least 60%

Other:

• No weight loss of more than 10% in the past 3 months
• No uncontrolled infection
• No serious medical risk factors involving any of the major organ systems that would preclude adherence to the study treatment schedule

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent immunotherapy

Chemotherapy:

• No prior chemotherapy
• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to the chest
• Maximum length of the esophagus receiving 40 Gy no greater than 18 cm
• Maximum length of the esophagus receiving 66 Gy no greater than 12 cm
• Must limit the spinal cord dose to a maximum of 50 Gy
• Must be able to exclude 25% of the heart from the boost volume

Surgery:

• Not specified

Other:

• No other concurrent experimental medications

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jose Belderbos, MD

Role: STUDY_CHAIR

The Netherlands Cancer Institute

Locations

Algemeen Ziekenhuis Middelheim

Antwerp, , Belgium

Hopital de Jolimont

Haine-Saint-Paul, , Belgium

CHR de Grenoble - La Tronche

Grenoble, , France

Mutterhaus der Borromaerinnen

Trier, , Germany

Medisch Centrum Haaglanden

's-Gravenhage (Den Haag, the Hague), , Netherlands

Antoni van Leeuwenhoekhuis

Amsterdam, , Netherlands

Academisch Medisch Centrum

Amsterdam, , Netherlands

Gelre Ziekenhuizen - Lokatie Lukas

Apeldoorn, , Netherlands

Amphia Ziekenhuis

Breda, , Netherlands

Amphia Ziekenhuis - locatie Molengracht

Breda, , Netherlands

Reinier de Graaf Group

Delft, , Netherlands

Radiotherapeutisch Instituut-(Riso)

Deventer, , Netherlands

Catharina Ziekenhuis

Eindhoven, , Netherlands

Twee Steden Ziekenhuis Vestiging Tilburg

Tilburg, , Netherlands

Dr. Bernard Verbeeten Instituut

Tilburg, , Netherlands

Sophia Ziekehuis

Zwolle, , Netherlands

Western General Hospital

Edinburgh, Scotland, United Kingdom

Countries

Belgium; France; Germany; Netherlands; United Kingdom

References

Belderbos J, Uitterhoeve L, van Zandwijk N, Belderbos H, Rodrigus P, van de Vaart P, Price A, van Walree N, Legrand C, Dussenne S, Bartelink H, Giaccone G, Koning C; EORTC LCG and RT Group. Randomised trial of sequential versus concurrent chemo-radiotherapy in patients with inoperable non-small cell lung cancer (EORTC 08972-22973). Eur J Cancer. 2007 Jan;43(1):114-21. doi: 10.1016/j.ejca.2006.09.005. Epub 2006 Nov 3.

Reference Type: RESULT

PMID: 17084621 (View on PubMed)

Other Identifiers

EORTC-08972

Identifier Type: -

Identifier Source: secondary_id

EORTC-08972-22973

Identifier Type: -

Identifier Source: org_study_id